Article 3.Transitional measures as regards procedures concerning active substances
Article 4.Transitional measures as regards procedures concerning plant protection products
INTRODUCTION Information to be submitted, its generation and its presentation
1. The information submitted shall meet the following requirements.
1.1. The information shall be sufficient to evaluate efficacy and the...
1.2. Any information on potentially harmful effects of the plant protection...
1.3. Any information on potentially unacceptable effects of the plant protection...
1.4. The information shall include all relevant data from the scientific...
1.5. The information shall include a full and unbiased report of...
1.6. Where relevant, the information shall be generated using test methods,...
1.7. The information shall include a full description of the test...
1.8. Where relevant, the information shall be generated in accordance with...
1.9. The information shall include a list of endpoints for the...
1.10. The information shall include the proposed classification and labelling of...
1.11. Information as provided for in Commission Regulation (EU) No 283/2013...
1.12. The information provided for the plant protection product and that...
1.13. Where relevant, tests shall be designed and data analysed using...
1.14. Exposure calculations shall refer to scientific methods accepted by the...
2. The requirements set out in this Regulation shall represent the...
5. Tests on vertebrate animals
5.1. Tests on vertebrate animals shall be undertaken only where no...
5.2. The principles of replacement, reduction and refinement of the use...
5.3. Tests involving the deliberate administration of the active substance or...
5.4 For ethical reasons, study designs shall be carefully considered, taking...
6. For purposes of information and of harmonisation the list of...
PART A CHEMICAL PLANT PROTECTION PRODUCTS
SECTION 2 Physical, chemical and technical properties of the plant protection product
2.7. Storage stability and shelf-life: effects of temperature on technical characteristics...
2.8. Technical characteristics of the plant protection product
2.9. Physical and chemical compatibility with other products including plant protection...
SECTION 4 Further information on the plant protection product
1. The data supplied shall be sufficient to permit an evaluation...
2. The number of trials to be conducted and reported shall...
3. Sufficient data shall be submitted to confirm that patterns of...
4. In order to assess seasonal differences, if any, sufficient data...
5. If the trials from the first season adequately confirm the...
6.3. Information on the occurrence or possible occurrence of the development...
6.5. Observations on other undesirable or unintended side-effects
SECTION 9 Fate and behaviour in the environment
1.1. A realistic worst-case estimation shall be made of the expected...
1.2. For the purposes of the estimation of such concentrations the...
1.3. For the estimation of these concentrations all relevant information on...
1.4. When models are used for estimation of predicted environmental concentrations...
1.5. The information provided shall, where relevant, include that referred to...
2. For solid plant protection products, treated and coated seeds there...
9.1. Fate and behaviour in soil
9.4. Estimation of concentrations for other routes of exposure
SECTION 10 Ecotoxicological studies
1. Testing of the plant protection product shall be necessary where...
2. All potentially adverse effects found during routine ecotoxicological investigations shall...
3. Whenever a study implies the use of different doses, the...
4. Where exposure data are necessary to decide whether a study...
5. The requirements laid down in this Section shall include certain...
6. A detailed description (specification) of the material used as provided...
7. In order to facilitate the assessment of the significance of...
8. The ecotoxicological assessment shall be based on the risk that...
9. For those guidelines which allow for study to be designed...
10. For solid formulations an assessment of the risk from dust...
11. Higher tier studies using a plant protection product shall be...
12. Pending the validation and adoption of new studies and of...
10.7. Effects on other terrestrial organisms (flora and fauna)
PART B PREPARATIONS OF MICRO-ORGANISMS INCLUDING VIRUSES
(i) This Part provides data requirements for the authorisation of a...
(ii) Where relevant, data shall be analysed using appropriate statistical methods....
(iii) Pending the acceptance of specific guidelines at international level, the...
(iv) Whenever a study implies the use of different doses, the...
(v) Where testing is done, a detailed description (specification) of the...
1. IDENTITY OF THE PLANT PROTECTION PRODUCT
1.2. Manufacturer of the preparation and the micro-organism(s)
1.3. Trade name or proposed trade name, and manufacturer's development code...
1.4. Detailed quantitative and qualitative information on the composition of the...
(i) Each micro-organism that is subject to the application shall be...
(ii) For preparations the following information must be reported:
(iii) Co-formulants must where possible, be identified either by their International...
(v) Identification of contaminating micro-organisms and other components derived from production...
2. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT...
2.4. Flash point and other indications of flammability or spontaneous ignition...
2.7. Technical characteristics of the plant protection product
2.8. Physical, chemical and biological compatibility with other products including plant...
2.10. Summary and evaluation of data presented under points 2.1 to...
4. FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT
4.1. Packaging and compatibility of the preparation with proposed packaging materials...
4.3. Re-entry periods, necessary waiting periods or other precautions to protect...
4.4. Recommended methods and precautions concerning: handling, storage, transport or fire...
4.6. Procedures for destruction or decontamination of the plant protection product...
6.3. Information on the occurrence or possible occurrence of the development...
6.4. Effects on the yield of treated plants or plant products...
6.5. Phytotoxicity to target plants (including different cultivars), or to target...
6.6. Observations on undesirable or unintended side-effects, e. g. on beneficial...
6.7. Summary and evaluation of data presented under 6.1 to 6.6...
10. EFFECTS ON NON-TARGET ORGANISMS
(i) The information provided, taken together with that for the micro-organism(s),...
(ii) The choice of the appropriate non-target organisms for testing of...
(iii) In particular, the information provided for the plant protection product,...
(iv) There is a need to report all potentially adverse effects...
(vi) Where exposure data are necessary to decide whether a study...
(vii) In order to facilitate the assessment of the significance of...